PHEBURANE (SODIUM PHENYLBUTYRATE)
Summary
FDA approved PHEBURANE (SODIUM PHENYLBUTYRATE) by MEDUNIK. NDA (New Drug) approval (Type 5 - New Formulation or New Manufacturer) on 2022-06-17. PELLETS, ORAL.
Details
Source
Drug Approval
External ID
NDA216513-1
Action Date
2022-06-17
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
PHEBURANE (generic: SODIUM PHENYLBUTYRATE), PELLETS, ORAL. Application: NDA216513
Company
Context & Analysis
Frequently Asked Questions
How often does MEDUNIK have FDA actions?
This is the only FDA action we have on record for MEDUNIK in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "NDA216513-1" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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